Clinical Trial of Integrated Treatment Versus Standard Treatment in First Episode Psychosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Bispebjerg Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Ministry of the Interior and Health, Denmark
Ministry of Social Affairs, Denmark
University of Copenhagen
Copenhagen Hospital Corporation
Medical Research Council
Wørzners Foundation.
Information provided by:
Bispebjerg Hospital
ClinicalTrials.gov Identifier:
NCT00157313
First received: September 8, 2005
Last updated: April 25, 2006
Last verified: September 2005

September 8, 2005
April 25, 2006
January 1998
Not Provided
  • Psychotic symptoms at one and two year follow-up
  • Negative symptoms at one and two year follow-up
Same as current
Complete list of historical versions of study NCT00157313 on ClinicalTrials.gov Archive Site
  • Adherence at one and two year follow-up
  • Depression at one and two year follow-up
  • Suicidal behaviour at one and two year follow-up
  • Use satisfaction at one and two year follow-up
  • Quality of life at one and two year follow-up
Same as current
Not Provided
Not Provided
 
Clinical Trial of Integrated Treatment Versus Standard Treatment in First Episode Psychosis
Randomised Clinical Trial of Integrated Treatment Versus Standard Treatment in First Episode Psychosis

The purpose of the study was to evaluate the effects of integrated treatment for patients with a first episode of psychotic illness. We conducted a randomised clinical trial in Copenhagen Hospital Corporation and Psychiatric Hospital Aarhus, Denmark. We included 547 patients with first episode of schizophrenia spectrum disorder, who has not received antipsychotic medication for more than 12 weeks.

Patients were randomised to integrated treatment or standard treatment. The integrated treatment lasted for two years and consisted of assertive community treatment with programmes for family involvement and social skills training. Standard treatment offered contact with a community mental health centre.

We wanted to study the effect on psychotic (hallucinations and delusions)and negative (lack of initiative, apati, blunted affect) symptoms (each scored from 0 to a maximum of 5) at one and two years’ follow-up.

We found that integrated treatment improved clinical outcome and adherence to treatment. The improvement in clinical outcome was consistent at one year and two year follow-ups. We will study further outcome measures such as social network, quality of life, depression and suicidal behaviour.

Objectives: To evaluate the effects of integrated treatment for patients with a first episode of psychotic illness.

Design: Randomised clinical trial. Setting: Copenhagen Hospital Corporation and Psychiatric Hospital Aarhus, Denmark Participants: 547 patients with first episode of schizophrenia spectrum disorder.

Interventions: Integrated treatment and standard treatment. The integrated treatment lasted for two years and consisted of assertive community treatment with programmes for family involvement and social skills training. Standard treatment offered contact with a community mental health centre.

Main outcome measures: Psychotic and negative symptoms (each scored from 0 to a maximum of 5) at one and two years’ follow-up.

Results: At one year’s follow-up, psychotic symptoms changed favourably to a mean of 1.09 (standard deviation 1.27) with an estimated mean difference between groups of –0.31 (95% confidence interval –0.55 to –0.07, P=0.02) in favour of integrated treatment. Negative symptoms changed favourably with a estimated difference between groups of –0.36 (–0.54 to –0.17, P<0.001) in favour of integrated treatment. At two years’ follow-up the estimated mean difference between groups in psychotic symptoms was –0.32 (0.58 to –0.06, P=0.02) and in negative symptoms was –0.45 (–0.67 to –0.22, P<0.001), both in favour of integrated treatment. Patients who received integrated treatment had significantly less comorbid substance misuse, better adherence to treatment, and more satisfaction with treatment.

Conclusion: Integrated treatment improved clinical outcome and adherence to treatment. The improvement in clinical outcome was consistent at one year and two year follow-ups.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Psychotic Disorders
  • Schizophreniform Disorders
  • Schizoaffective Disorder
  • Psychosis, Brief Reactive
  • Schizophrenia, Borderline
  • Behavioral: Integrated treatment, family involvement
  • Behavioral: Social skills training
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
600
December 2005
Not Provided

Inclusion Criteria:

  • 18-45 years of age
  • F2 diagnosis in ICD 10
  • Address in Copenhagen, Frederiksberg or Aarhus
  • Antipsychotic medication not exceeding 12 weeks
  • Informed consent

Exclusion Criteria:

Both
18 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00157313
OPUS trial
Not Provided
Not Provided
Bispebjerg Hospital
  • Ministry of the Interior and Health, Denmark
  • Ministry of Social Affairs, Denmark
  • University of Copenhagen
  • Copenhagen Hospital Corporation
  • Medical Research Council
  • Wørzners Foundation.
Principal Investigator: Merete Nordentoft, Ph.D. Bispebjerg Hospital, department of psychiatry, University of Copenhagen
Bispebjerg Hospital
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP